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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000965303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
13/07/2026
Date registered
Help: Date registered
6/08/2026
Date last updated
Help: Date last updated
6/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Test a New Multi-Analyte Sensor During Meal Tests
Scientific title
Feasibility Study of a Multi-Analyte Sensor for Metabolic Monitoring During Meal Tests
Additional trial identifiers [1] 317889 0
None
Universal Trial Number (UTN)
Trial acronym
KeLOG-MT
Related trial records

Health condition
Health condition(s) studied:
Diabetes mellitus 342834 0
Condition category
Condition code
Metabolic and Endocrine 338950 338950 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
All eligible participants will be transferred to the investigational device, the PercuSense Atlas Health Multi-Analyte Sensor (MAS). In addition the participant will also wear the commercially available continuous glucose monitor (CGM), the Abbott Libre 2 Plus.

This is a single-site, participant-blinded feasibility study designed to generate preliminary data on continuous interstitial glucose, ketone, lactate, and oxygen measurements using the PercuSense MAS during standardised metabolic challenges. Participants will be recruited from St Vincent’s Hospital Melbourne. Two cohorts will be enrolled: Cohort 1 will include 10 adults with a clinical diagnosis of diabetes treated with insulin, and Cohort 2 will include 10 adults without diabetes. Following written informed consent, participants will be screened for eligibility which involves medical history review, clinical assessment and physical examination.

On Day 1, eligible participants will undergo insertion of masked study devices. Two MAS devices will be inserted subcutaneously, one in the outer aspect of the arm on each side to enable continuous monitoring of glucose, ketone, lactate, and oxygen. A commercially available continuous glucose monitoring device (CGM; Abbott Libre 2 Plus) will also be inserted according to participant preference into the abdomen, thigh or in the back postero-laterally just above the beltline. An intravenous cannula will then be placed for serial venous blood sampling. Blood samples will be collected at baseline and at 15-minute intervals throughout the study visit (approximately 6 hours).

Participants will begin a standardised meal test. A standardised test meal requires participants to eat a meal containing 65g of carbohydrates. For example, a toasted cheese sandwich and a glass of milk or a fruit juice. Following the meal test, a blood pressure cuff will be applied to the upper arm above the investigational sensor and inflated to 50mmHg above systolic pressure and also perform handgrip exercises to achieve reduced blood flow with the aim of inducing a transient increase in lactate for up to 10 minutes. The arm cuff will then be deflated at the end of the 10 minutes.

Subsequently, participants will consume an exogenous ketone drink. The ketone drink (100 mLs) contains a pure ketone substance dissolved in a commercially available low-calorie drink. The first blood collection will commence before the meal test to collect baseline values and then continue every 15 minutes over the duration of the study visit (approximately up to 80mL over 6 hours), with an additional two blood collections (up to 10mL) during the arm blood pressure cuff procedure

On Days 2 and 3, participants will remain in the outpatient setting (home) while continuing to wear the MAS and CGM devices. During this period, they will perform capillary glucose and ketone measurements via finger-prick testing.

On Day 4, participants will return to the clinical site to repeat the standardised meal test, blood sampling protocol, arm cuff blood flow restriction procedure, and administration of a second ketone drink consistent with Day 1. At End of Study all study devices (MAS and CGM), will be removed and study phone returned at clinical site.

Adherence of participants to the intervention will be monitored throughout the study. This will be achieved through study team members reviewing device data by direct observation during the meal tests and uploads into the mobile app platform at other times.
Intervention code [1] 334735 0
Treatment: Devices
Description of the comparator or control
All participants will be transferred to the investigational device the PercuSense Atlas Health Multi-Analyte Sensor (MAS). The MAS will be used as a comparator in this study comparing readings to the commercial CGM and reference values (Glucose [Yellow Springs Instrument (YSI), CGM and meter], Lactate [YSI], ketone [meter]) .
Data collected from each cohort will be analysed only within that individual cohort. No comparisons will be made between cohorts.
Control group
Active

Outcomes
Primary outcome [1] 346188 0
Duration of sensor function (hours) according to insertion site.
Timepoint [1] 346188 0
From time of device insertion until end of study
Primary outcome [2] 346189 0
The number of failed insertions
Timepoint [2] 346189 0
From time of device insertion until end of study
Primary outcome [3] 346360 0
The number of sensor failures
Timepoint [3] 346360 0
From time of device insertion until end of study
Secondary outcome [1] 464938 0
Comparisons to determine MAD/ Mean Absolute Relative Difference (MARD) will be made between MAS glucose sensor measurements and reference values (YSI, CGM and meter).
Timepoint [1] 464938 0
From time of device insertion until end of study every 15 minutes.
Secondary outcome [2] 464940 0
Comparisons to determine MAD/ MARD will be made between MAS lactate sensor measurements and reference values (YSI).
Timepoint [2] 464940 0
From time of device insertion until end of study every 15 minutes.
Secondary outcome [3] 464941 0
Comparisons to determine MAD/ MARD will be made between MAS ketone sensor measurements and reference values (ketone meter).
Timepoint [3] 464941 0
From time of device insertion until end of study every 15 minutes.

Eligibility
Key inclusion criteria
Cohort 1
• Men and non-pregnant women
• Aged 18 years of age and over
* Clinical diagnosis of type 1 or type 2 diabetes mellitus, currently managed with insulin therapy

Cohort 2
• Men and non-pregnant women
• Aged 18 years of age and over
• Do not have a diagnosis of diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
• Recent hospital visit within last three months for hypoglycaemia or diabetic ketoacidosis (DKA)
• Severe tape allergy
• Major medical or psychiatric illness that would interfere with protocol adherence
• Individuals unable to read, speak, or understand English, or those for whom translation services/certified translated documents are not available
• Any other reason that in the opinion of the investigator would prevent the subject from completing study procedures.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/08/2026
Actual
Date of last participant enrolment
Anticipated
30/07/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29829 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 46180 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 322428 0
Charities/Societies/Foundations
Name [1] 322428 0
Helmsley Charitable Trust
Country [1] 322428 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 325353 0
None
Name [1] 325353 0
Address [1] 325353 0
Country [1] 325353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320922 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 320922 0
Ethics committee country [1] 320922 0
Australia
Date submitted for ethics approval [1] 320922 0
15/05/2026
Approval date [1] 320922 0
06/07/2026
Ethics approval number [1] 320922 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152082 0
Prof David O'Neal
Address 152082 0
St Vincent's Hospital Melbourne, Level 4, Clinical Sciences Building, 29 Victoria Parade, Fitzroy, VIC, 3065
Country 152082 0
Australia
Phone 152082 0
+61 425731665
Fax 152082 0
Email 152082 0
[email protected]
Contact person for public queries
Name 152083 0
Dr Dale Morrison
Address 152083 0
Diabetes Technology Research Group, Level 4, Daly Wing North, 35 Victoria Parade, Fitzroy, VIC, 3065
Country 152083 0
Australia
Phone 152083 0
+61 3 9231 2757
Fax 152083 0
Email 152083 0
[email protected]
Contact person for scientific queries
Name 152084 0
Dr Dale Morrison
Address 152084 0
Diabetes Technology Research Group, Level 4, Daly Wing North, 35 Victoria Parade, Fitzroy, VIC, 3065
Country 152084 0
Australia
Phone 152084 0
+61 3 9231 2757
Fax 152084 0
Email 152084 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.